Soft tissue fixation devices and methods

ABSTRACT

Filamentary fixation devices may be used in a variety of surgical procedures to secure soft tissue to bone. The present invention provides various devices, systems, kits and instrumentation for performing such surgical procedures including preparation of soft tissue and bone, preparation and manipulation of such filamentary fixation devices, and insertion and utilization of the fixation devices within a patient&#39;s anatomy. In one embodiment, a method for securing soft tissue to bone, the method includes accessing the soft tissue and the bone, passing a filament through the soft tissue, preparing a bore hole in the bone, loading the filament into a filamentary fixation device, implanting the filamentary fixation device, with the filament, into the bore hole, and tensioning the filament so that the filamentary fixation device and filament are secured within the bore hole.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.13/588,586 filed on Aug. 17, 2012, which claims the benefit of thefiling date of U.S. Provisional Application No. 61/679,336 filed Aug. 3,2012, the disclosures of which are hereby incorprated herein byreference.

BACKGROUND OF THE INVENTION

Traditional fixation devices, such as suture anchors or tissue anchors,are typically made of metal or hard plastic, and include a structurewhich connects or otherwise secures a filament, such as a suture, or aportion of tissue, to the body of the device. In certain applications,these devices have a diameter suitable to hold the devices within abone. Such devices may also include additional structures to dig intothe bone, such as wings, barbs, threads, or the like.

However, such traditional devices tend to be large in diameter, and mustinclude sufficient material, or other additional structures, towithstand the forces pulling against the device, whether via a suture ordirectly against the device itself. The size of such devices may limitthe possible implantation locations in the body, as sufficient bone massis required to accommodate the device. Moreover, a large hole must bedrilled into the bone to allow for passage of the device through thecortical layer and into the cancellous bone. The larger drill holes maybe too invasive resulting in excessive loss of healthy bone, or creationof a large repair site.

A recent trend in fixation device technology is the “soft” device, alsoreferred to as a “filamentary” fixation device, in which the deviceitself is constructed of a filamentary material. Such filamentaryfixation devices may provide solutions to the various problemsencountered with traditional devices, as summarized above.

BRIEF SUMMARY OF THE INVENTION

Such filamentary fixation devices may be used in a variety of surgicalprocedures to secure soft tissue to bone. The present invention providesvarious devices, systems, kits and instrumentation for performing suchsurgical procedures including preparation of soft tissue and bone,preparation and manipulation of such filamentary fixation devices, andinsertion and utilization of the fixation devices within a patient'sanatomy. Furthermore, the devices and instrumentation of embodiments ofthe present invention can be used in methods to perform knotless tissuerepair procedures. The devices and instruments of embodiments of thepresent invention may provide for improved repairs of soft tissueincluding the ability to prepare and use smaller bore holes in bone,ability to perform methods of soft tissue repair in a less invasivemanner, and the ability to perform such methods at various angles,approaches, and directions of entry, such that soft tissue injuries indifficult to reach anatomical locations may be more easily accessed.

In one embodiment, the present invention includes a system for therepair of soft tissue, the system including at least one instrumentadapted to implant a filamentary fixation device into bone, and thefilamentary fixation device. The system may further include at least onefilament adapted to cooperate with the fixation device.

In another embodiment, the present invention includes a system for therepair of soft tissue, the system including a filamentary fixationdevice, an inserter, a guide, and a loading device. The inserterincludes a distal portion for accommodating the filamentary fixationdevice, and an at least one groove extending along at least a portion ofa length of the inserter from a distal-most end towards a proximal end.The guide is cannulated along at least a portion of its length andincludes a distal tip including an engagement surface for engaginganatomy and a handle on a proximal end. The loading device may include acasing adapted to accommodate at least a portion of the filamentaryfixation device and at least a portion of the inserter, and a channelextending from a first side of the casing to a second side of thecasing.

Further, in another aspect of the above embodiment, the filamentaryfixation device may be adapted to be positioned on the distal end of theinserter and within at least a portion of the channel of the loadingdevice. The loading device may further include a second channelextending from the first side of the housing to a third side of thehousing. The first and second channels may further follow routes withinthe housing. Further, the first and second channels may intersect alongat least a portion of their lengths, and further may be circuitous ortortuous. The channels may further be sized to accommodate at least oneof a threading filament and a filament therein. The threading filamentmay include a wire, a suture, or a combination of the wire and suture.The threading filament may be positioned within the first channel, thesecond channel, the filamentary fixation device, or any combination, andmay further be adapted to thread the filament into the loading device.

In another aspect of this embodiment, the housing of the loading devicemay include two or more independent portions adapted to be positionedtogether or separated from one another in a hinged relationship, forexample.

In yet another aspect of this embodiment of the present invention, theinserter may further include a second groove extending along at least aportion of the length of the inserter from the distal-most end towardsthe proximal end. The distal portion of the inserter may have an I-beamshape, wherein the filamentary fixation device is positioned within thefirst and second grooves and looped around or folded over a saddle atthe distal-most end. The distal-most end of the inserter may be a forkedend, a flat blade end, a flat blunt end, or the like. The inserter mayinclude a handle at its proximal end. Further, portions of the inserterand guide shafts may form an abutment or stop structure. The guide mayhave a curve along at least a portion of its length, and the insertermay include a flexible portion and be adapted to pass through thecannula along the length of the guide and through the curved portion ofthe guide.

In a further aspect of this embodiment, the system may further include adrill having a drill head and a shaft. At least a portion of the shaftmay be flexible and be adapted to pass through the cannula along thelength of the guide and through the curved portion of the guide. Thedrill may further include a bushing positioned along at least a portionof the length of the shaft.

In another embodiment, the present invention may include a loadingdevice for preparing a filamentary fixation device including a housingadapted to accommodate at least a portion of the filamentary fixationdevice, and a channel extending from a first side of the housing to asecond side of the housing, and a second channel extending from thefirst side of the housing to a third side of the housing, wherein thefirst and second channels follow routes within the housing. Further, thefirst and second channels may intersect along at least a portion oftheir lengths. The channels may further be sized to accommodate afilament therein. The filament may be positioned within the firstchannel, the second channel, the filamentary fixation device, or anycombination. The housing of the loading device may include two or moreindependent portions adapted to be positioned together or separated fromone another. Additionally, the loading device may be adapted toaccommodate at least a portion of an inserter, wherein the inserter canengage the filamentary fixation device within the loading device.

In yet another embodiment, the present invention may include a systemfor preparing a bone for fixation of soft tissue, the system including aguide and a drill having a bushing positioned thereon. The bushing mayhave a length, wherein at least a portion of the length may becompressible, expandable, or both. Specifically, the bushing may have atleast one spring-like structure incorporated into its length, may beconstructed of an elastic material, such as plastic or or the like, ormay include at least one cut or slot, to create an elastic structure.

In another embodiment, the present invention includes a surgicalinstrument including an instrument body including a shaft having adistal end, a proximal end and a length therebetween and a bushinghaving a length, wherein at least a portion of the length of the bushingincludes a spring portion including a resilient member, wherein thebushing is cannulated such that the shaft of the instrument ispositioned therethrough. The bushing may further include a solid portionalong at least a portion of the length, and alternatively, the bushing,along its length, may include more than one spring portion and more thanone solid portion, each spring portion separated from one another by asolid portion. In another alternative, the spring portion may extendalong the entire length of the bushing. The instrument of thisembodiment may be a drill or an implant inserter. In the example of adrill, having a distal drilling tip, the bushing may be positioned onthe shaft of the drill adjacent to the distal drilling tip. Theinstrument of this embodiment may be positioned through a cannulatedguide, the guide may have a length and a curved portion along at least aportion of its length, wherein the bushing and shaft of the instrumentmay be adapted to pass through the curved portion of the cannulatedguide. The bushing further has an outer diameter sufficient to maintainthe instrument to be substantially co-axial with the cannulated guide.The resilient member of the spring portion may be a spring or a solidstructure having at least one cut, either of said spring or said cutadapted to impart compressibility, expandability, or both. The springportion may be made of PEEK, nitinol, stainless steel, Radel, ABS,polycarbonate, polyethylene, PTFE, or any combination.

In yet another embodiment, the present invention includes a drill foruse in soft tissue repair, the drill comprising a shaft having a distalend, a proximal end and a length therebetween, a distal drilling tip,and a bushing having a length, wherein at least a portion of the lengthof the bushing includes a solid portion and at least another portion ofthe length of the bushing includes a spring portion, said spring portionincluding a resilient member. The distal-most portion of the bushing maybe the solid portion. Moreover, the bushing, along its length, mayinclude more than one spring portion and more than one solid portion,each spring portion separated from one another by a solid portion. Thebushing may also be cannulated such that the shaft of the drill may bepositioned therethrough, and the bushing may be positioned on the shaftadjacent the distal drilling tip. While positioned on the shaft, thebushing may be rotatable, slideable, or both. The drill of thisembodiment is adapted to be positioned through a cannulated guide, saidcannulated guide having a length, a curved portion along at least aportion of its length, and a longitudinal axis extending therethrough,and the bushing may include an outer diameter adapted to position theshaft of the drill substantially coaxial with the longitudinal axis ofthe cannulated guide.

In still another embodiment, the present invention includes a method ofpreparing a bone hole in bone, the method including accessing the bone,determining a position for the bone hole, and preparing the bone holeusing a surgical drill, the drill comprising a shaft having a distalend, a proximal end and a length therebetween, a distal drilling tip,and a bushing having a length, wherein at least a portion of the lengthof the bushing includes a solid portion and at least another portion ofthe length of the bushing includes a spring portion, said spring portionincluding a resilient member.

In a further embodiment, the present invention may include a cannulatedguide for use in the repair of soft tissue, the guide including aproximal end, a distal end and a length therebetween, the distal endhaving a distal tip including an engagement surface having a generallyangled face and an at least one edge engagement feature. The edgeengagement feature may have a cross-sectional shape suitable forengagement with the bone. For example, the cross-sectional shape may bea “c” shape, a “u” shape, a “v” shape, or the like. The engagementfeature may be positioned on the engagement surface to provide aprescribed offset from the anatomical edge. The angled face, and atleast one edge engagement feature, may be dimensioned to be suitable forengaging anatomy for the repair of a hip labrum, for example. The guide,along at least a portion of its length, may include at least one curve,or alternatively, two or more curves. The distal end of the guide mayfurther include a window through a portion of a sidewall of the guide.

In yet a further embodiment, the present invention may include a methodof securing soft tissue to bone, the method including accessing the softtissue and the bone, passing a filament through the soft tissue,preparing a bore hole in the bone, loading the filament into afilamentary fixation device, implanting the filamentary fixation device,with the filament, into the bore hole, and tensioning the filament sothat the filamentary fixation device and filament are secured within thebore hole. The soft tissue to be secured may be, for example, shoulderlabrum, hip labrum, rotator cuff, or the like. During the loading step,first and second ends of the filament may each pass through first andsecond ends of the filamentary fixation device. An inserter or likeinstrument may be used to implant the filamentary fixation device andfilament within the bore hole. Also, following the accessing step, theremaining steps may be performed through a cannulated guide, and suchguide may further include a curved portion along at least a portion ofits length. Both the inserter and a drill, for preparing the bore hole,may include a flexible portion along at least a portion of therespective lengths to pass through the curved portion of the guide.

In another embodiment, the present invention may include a method forrepairing a torn rotator cuff, the method including implanting a boneanchor in a medial location, underneath the rotator cuff, having afilament being associated with the bone anchor, the filament having alength and an end portion having an end, passing the end through therotator cuff and positioning the end portion over the rotator cuff in alateral direction, preparing a bore hole in the bone in a positionlateral to the rotator cuff, loading the filament into a filamentaryfixation device, implanting the filamentary fixation device, with thefilament, into the lateral bore hole such that the end of the endportion is positioned outside of the bore hole, and tensioning the endof the filament so that the filamentary fixation device and filament aresecured within the lateral bore hole and the rotator cuff is drawntowards the lateral bore hole.

Continuing with this embodiment, the filament may further include asecond end portion and a second end, wherein the end portions of thefilament extend from the bone anchor. In this configuration, the methodmay further include passing the ends of the filament through the rotatorcuff and positioning the end portions over the rotator cuff in a lateraldirection, preparing a second bore hole in the bone in a positionlateral to the rotator cuff and adjacent to the first bore hole, loadingthe second end portion of the filament into a second filamentaryfixation device, implanting the second filamentary fixation device, withthe second end portion, into the second lateral bore hole such that theends of the end portions are positioned outside of the bore holes, andtensioning the end of the second end portion so that the filamentaryfixation device and second end portion are secured within the secondlateral bore hole and the rotator cuff is drawn towards the secondlateral bore hole. Once the ends of the filament are passed through therotator cuff, the end portions may be tied into a knot to compress aportion of the rotator cuff between the knot and the bone anchor.

In another alternative configuration of this embodiment, where thefilament again may include a second end portion and a second end,wherein the end portions of the filament extend from the bone anchor,the method may optionally include passing the ends of the filamentthrough the rotator cuff and positioning the end portions over therotator cuff in a lateral direction, loading the end portions of thefilament into the filamentary fixation device, implanting thefilamentary fixation device, with the filament, into the lateral borehole such that the ends of the end portions are positioned outside ofthe bore hole, and tensioning the ends of the filament so that thefilamentary fixation device and filament are secured within the lateralbore hole and the rotator cuff is drawn towards the lateral bore hole.

In yet another embodiment, the present invention may include a method ofloading a filament onto a filamentary fixation device, the methodincluding obtaining an end of the filament; engaging the end with athreading filament, wherein the threading filament is positioned withina loading device containing the filamentary fixation device, thethreading filament passing through at least a portion of the filamentaryfixation device; and tensioning the threading filament to pull the endof the filament into the loading device and through at least a portionof the filamentary fixation device.

The filament of this embodiment may, prior to the engaging step, bepassed through a tissue, a suture anchor, or both. After the tensioningstep, the method may further include disengaging the end of the filamentfrom the threading filament. After the tensioning step, the method mayalso include opening the loading device and removing the filamentaryfixation device and filament from the loading device. The loading devicemay also house an inserter instrument, such that, the step of removingthe filamentary fixation device and filament from the loading devicefurther includes securing the filamentary fixation device and filamentto the inserter, and removal of the inserter, with the filamentaryfixation device and filament, from the loading device.

In yet another embodiment, the present invention may include a method ofloading a filament onto a filamentary fixation device, the methodincluding obtaining first and second ends of the filament, having alength between the ends; engaging the first and second ends with firstand second threading filaments, wherein the threading filaments arepositioned within a loading device housing the filamentary fixationdevice, the threading filaments passing through at least a portion ofthe filamentary fixation device; and tensioning the threading filamentsto pull the first and second ends of the filament into the loadingdevice and through at least a portion of the filamentary fixationdevice.

The filament of this embodiment may, prior to the engaging step, bepassed through a tissue, a suture anchor, or both. After the tensioningstep, the method may further include disengaging the first and secondends of the filament from the first and second threading filaments.After the tensioning step, the method may also include opening theloading device and removing the filamentary fixation device and filamentfrom the loading device. The loading device may also house an inserterinstrument, such that, the step of removing the filamentary fixationdevice and filament from the loading device further includes securingthe filamentary fixation device and filament to the inserter, andremoval of the inserter, with the filamentary fixation device andfilament, from the loading device.

In another embodiment, the present invention includes a system for therepair of soft tissue including at least one filament, at least onefilamentary fixation device, at least one instrument for insertion ofthe filament and fixation device, and a surgical procedure. The surgicalprocedure may include instructions or protocol for using the filament,fixation device, and instrument to repair soft tissue.

In an associated embodiment, the present invention includes a method ofproviding instructions or information to practice any of the variousmethods of performing soft tissue repair described herein. For example,the method may include supplying a surgical protocol, or like document,to provide step-by-step instructions for performing any of the methodembodiments of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate one embodiment of a filamentary fixationdevice in accordance with the present invention.

FIG. 2 illustrates another embodiment of a filamentary fixation devicein accordance with the present invention.

FIG. 3A illustrates one embodiment of an inserter, where a portion of ashaft of the inserter is transparent for illustrative purposes, inaccordance with the present invention.

FIGS. 3B-3D illustrate various aspects of the inserter of FIG. 3A, inaccordance with the present invention.

FIG. 4 illustrates the inserter of FIGS. 3A-D having a filamentaryfixation device positioned thereon, in accordance with the presentinvention.

FIGS. 5A-5C illustrate various aspects of one embodiment of a cannulatedguide in accordance with the present invention.

FIGS. 6A and 6B illustrate one arrangement of the cannulated guide ofFIGS. 5A-5C and the inserter of FIGS. 3A-3D, where FIG. 6B illustrates aportion of the cannulated guide as transparent to show underlyingdetails, in accordance with the present invention.

FIG. 7A illustrates another embodiment of a cannulated guide inaccordance with the present invention.

FIG. 7B illustrates details of a portion of the cannulated guide of FIG.7A in accordance with the present invention.

FIGS. 8A-8C illustrate another embodiment of the cannulated guide inaccordance with the present invention.

FIGS. 9A-9C illustrate one embodiment of a loading device in accordancewith the present invention.

FIGS. 10A-10B illustrate one embodiment of a drill, including a bushingpositioned thereon in accordance with the present invention.

FIGS. 11A-11C illustrate various alternative embodiments of the bushingin accordance with the present invention.

FIG. 12 illustrates one aspect of one embodiment of a method inaccordance with the present invention.

FIG. 13 illustrates one aspect of another embodiment of a method inaccordance with the present invention.

FIG. 14 illustrates one aspect of one embodiment of a method inaccordance with the present invention.

FIG. 15 illustrates one aspect of another method in accordance with thepresent invention.

FIGS. 16A and 16B illustrates various steps of yet another embodiment ofa method in accordance with the present invention.

DETAILED DESCRIPTION

The disclosure herein relates to various devices and instrumentation foruse with a filamentary fixation device of the present invention. Moreparticularly, the various devices and instrumentation may be used with afilamentary fixation device for the repair of soft tissue. Such devicesand instrumentation may be used in a wide array of methods, systems,kits, and like embodiments, of which various exemplary embodiments willbe described in detail below. Other embodiments utilizing the variousdevices and instrumentation are also envisioned.

As used herein, the term “surgeon” may refer to any clinician, nurse,assistant, doctor or the like who may utilize the present invention. Theterms “proximal” and “distal” are used herein relative to the surgeon,such that “proximal” means closer to the surgeon and “distal” meansfurther from the surgeon.

The term “soft tissue” refers to any tissue such as ligaments, tendons,capsule, cartilage, meniscus, and the like. The term “bone” refers tobone or hard tissue, and includes both cortical and cancellous bone.

While the devices, instruments, kits, systems and methods of the presentinvention are intended for use in arthroscopic surgical applications,they may of course be used in open surgical procedures.

Generally speaking, the present invention, in one embodiment, is asystem for repairing soft tissue, the system includes at least afilamentary fixation device 10, a filament 15, an inserter 20, acannulated guide 40, and a loading device 50. The system can furtherinclude a drill 60 having a bushing 67 thereon. The system may stillfurther include various instrumentation such as awls and trocars. Any ofthe inserter, drill, awl or trocar is capable of being positionedthrough the cannulated guide, as will be discussed in greater detailbelow.

Various embodiments of the filamentary fixation device 10, 110 of thepresent invention are illustrated in FIGS. 1A-2. FIGS. 1A-1B illustrateone embodiment of the filamentary fixation device 10 having a filament15 loaded thereon. The device 10 includes a substantially tubular orcylindrical shape with a first end 12 and a second end 13, and a hollowinterior 11. Alternatively, the device 10 may have a substantially flatshape. The device 10 is formed of filament material. The filament 15,also formed of filament material, includes a first end 17′ and a secondend 18′ and a length therebetween. Once loaded (discussed below) ontothe device 10, the filament 15, so configured, may include a loopportion 16, a first portion 17, and a second portion 18. The filament 15as illustrated may further be configured to include first and secondsecondary loops 19 a, 19 b such that the filament 15, starting with loop16, passes transversely through the device 10 and then into the ends 12,13 of the device, forming secondary loops 19 a, 19 b. The first andsecond portions 17, 18 then extend through the interior 11 and out theopposite end 12, 13 of the device 10, from which they entered, andterminate at first and second ends 17′, 18′ of the filament 15. As willbe discussed in more detail below, such an arrangement creates, for eachfilament portion 17, 18, a one-way tensioning mechanism such that thefilament ends 17′, 18′ may be tensioned, by pulling in one direction,and such tension, once applied, will not loosen under normal operation.

FIG. 2 illustrates another embodiment of the filamentary fixation device110 having a filament 115 loaded thereon. In this embodiment, device 110includes a substantially tubular or cylindrical shape with a first end112 and a second end 113, and a hollow interior 111. The device 110 isformed of filament material. Alternatively, the device 110 may have asubstantially flat shape. The filament 115, also formed of filamentmaterial, includes a first end 117′ and a second end 118′ and a lengththerebetween. Once loaded (discussed below) onto the device 110, thefilament, so configured, may include a loop portion 116, a first portion117, and a second portion 118 such that the filament 15, starting withloop 16, proceeds into the ends 112, 113 of the device 110. The firstand second portions 117, 118 then extend through the interior 111 andout the opposite end 112, 113 of the device 110, from which theyentered, and terminate at first and second ends 117′, 118′. Once again,this configuration may create a one-way tensioning mechanism as to eachend portion 117, 118.

Both the device 10, 110 and filament 15, 115 are formed of flexibleelongate materials may be fine or thinly spun thread, wire, fiber, orany other suitable material. For example, the material may includesuture material such as polyester, UHMWPE polymer, or the like. However,the materials for either the device or the filament are not necessarilylimited to a thread, suture, fiber, or wire. Additionally, the deviceand filament may be formed of the same material as once another ordifference materials from one another. Further, the device and filamentmay have differing construction from one another, such as differentweaving, density, or the like.

Further, the device 10 should have a diameter which is larger than thatof the filament 15, such that the filament may be positioned within thehollow interior 11 of the device. Preferably, the diameters should besufficiently sized to allow two portions of filament 15 to be positionedwithin the interior 11, as illustrated. While the material of the device10 should be hollow, the material of the filament 15 may have a hollowcore or a solid core, depending on the application and the strength ofthe material required. Alternatively, the filament 15 may be constructedof metal wire or other like material.

With respect to the embodiment of the device having a substantially flatshape, rather than positioning the filament through a hollow interior,the filament may instead pass through the device in a directiontransverse to the longitudinal axis of the device. The filament may passat least once through the device in this fashion. For example, thefilament may pass through a first side of the flat-shaped device and outa second side. Then, the filament may pass through the second side, at asecond location, and out the first side. This passage of the filamentmay be repeated as desired. Other configurations are also envisionedusing such a flat-shaped device.

While FIGS. 1-2 illustrate certain embodiments of the filamentaryfixation device and filament of the present invention, it is envisionedthat alternative configurations of the device may also be incorporatedinto the various systems, methods as well as used with the variousinstrumentation herein. For example, alternative configurations aredisclosed in U.S. application Ser. No. 13/303,849, filed Nov. 23, 2011,and U.S. Pat. Nos. 5,989,252 or 6,511,498, the entireties of which areincorporated by reference herein as if fully set forth herein. Otheralternative configurations are also envisioned.

FIGS. 3A-D illustrate one embodiment of an inserter 20 of the presentinvention for use with a filamentary fixation device, such as device 10of FIGS. 1A-1B, for example. The inserter 20 includes a distal portion30 and a proximal portion including a handle 21, and a shaft extendingtherebetween. The shaft includes a proximal shaft 22 and a distal shaft24, where the proximal shaft 22 has a larger diameter than the distalshaft 24, as illustrated. At the juncture of the proximal and distalshafts is a shoulder 23, or like structure, which may operate as a stopwhen the inserter 20 is used in conjunction with a cannulated guide 40(discussed in greater detail below). A laser marking 81, gap in material(e.g., an incomplete cylinder of material at the proximal end), or thelike, may also be positioned on the proximal shaft 22 to denote theposition of the inserter 20 to the surgeon during use (e.g., when thedistal portion 30 is within a surgical site in a patient). For example,as described below, the laser marking 81 may assist the surgeon inknowing where the stop 23 is positioned within the cannulated guide 40,and thus, where the distal portion 30 of the inserter 20 is relative to,for example, the bone or a prepared bore hole in the bone. Inserter 20may be constructed of any suitable material for surgical applicationsincluding stainless steel, Nitinol, plastics or the like. Preferably,stainless steel may be used.

The distal portion 30, as seen best in FIG. 3D, may include an I-beamshape along its length which includes I-beam struts 34, 35 and a centralsupport 36. The I-beam struts may have a substantially curved outersurface to minimize sharp corners along the distal portion 30 as well asto mimic the shape of the cannula of the cannulated guide, as discussedbelow. The I-beam shape provides for first and second grooves 32 a, 32 bdefined on either side of the central support 36 by the struts 34, 35.The distal-most end of distal portion 30 includes a saddle 33 definedbetween I-beam projections 31 a, 31 b and a cut-out portion of thecentral support 36. The I-beam projections 31 a, 31 b, as illustrated,form a forked end. However, the distal-most end of the inserter may haveother shapes such as a flat blade end, a flat blunt end, or the like. Asillustrated in FIG. 4, the grooves 32 a, 32 b and saddle 33 (see FIG.3D) are adapted to accommodate a filamentary fixation device (such asdevice 10 of FIGS. 1A-1B) therein, and as such the distal-most end mayinclude any structure suitable for accommodating the filamentaryfixation device. The distal portion 30 of the inserter may have a widthof about 1.3 mm, measured from the outer edges of the I-beam struts 34,35 as to the embodiment of FIG. 3D. At such a dimension, an inserter 20constructed of stainless steel may have sufficient flexibility to passthrough a curved cannulated guide (see FIG. 7A) while still havingsufficient strength when, for example, the surgeon presses or uses amallet on the inserter to implant the device 10 into a bore hole inbone.

FIG. 3C illustrates the proximal portion of the inserter 20 includinghandle 21. The handle includes a filament engagement structure 25including first and second cleats 26 a, 26 b. For example, theengagement structure 25 may be used to secure filament 15 after it hasbeen loaded into device 10 and the device and filament have been securedto the distal portion 30 of the inserter 20, such that the first andsecond portions 17, 18 of the filament 15 may be tensioned proximally,towards handle 21, and engaged within the engagement structure 25.

FIGS. 5A-5C illustrate one embodiment of the cannulated guide 40 havinga proximal end including handle 41 and a distal end including distal tip45, and a shaft 42 positioned between handle 41 and distal tip 45. Atleast a portion of the length of the cannulated guide is cannulated.Preferably, and as illustrated, the cannulated guide may have acannulation 44 through the entire length of the guide 40, extending fromthe proximal-most end of the handle 41, through the handle and shaft 42,and out the distal-most end of the distal tip 45. This cannulation 44 ofthe guide may be adapted to accommodate the inserter 20 and/or the drill60 (described below). The overall length of the guide may be dependenton the anticipated surgical procedure, anticipated directional approachby the surgeon, as well as other factors. For example, in a preferredembodiment, a possible guide length for use in a shoulder application,such as for the repair of a rotator cuff, may be about 5.2 in., while apossible guide length for use in an instability application, such as forthe repair of a hip or shoulder labrum, may be about 7.1 in. Of course,these dimensions are only exemplary and other lengths are envisioned.

With reference to FIGS. 5B and 5C, the distal tip 45, extending fromshaft 42, includes an at least one window 46 and an engagement surface47. The distal tip may include more than one window 46 a, 46 b, 46 c(see FIG. 5C) to provide viewing capability, for the surgeon, of thecannulation 44 from a variety of directions. The engagement surface 47is adapted to engage a portion of the anatomy of the patient, andspecifically, to engage the surface of the bone, or the like. Asillustrated, the surface 47 may include a “crown” shape including fourprongs 48 a, 48 b, 48 c, 48 d, wherein the prongs may engage bone tomaintain a stable connection between the bone and the guide 40. Otherengagement surface structures are also envisioned which may be usefulfor particular angles of approach to certain anatomy, as well as thebone surface or other anatomical shape to which the distal tip of theguide must engage. For example, FIGS. 8A-8C illustrate an alternativedistal tip 245 having an engagement surface 247 including an angled faceextending to a distal-most end 248 a and including an at least one edgeengagement feature 248 b which may be positioned on the engagementsurface 247. This embodiment will be discussed further below.

Continuing from the embodiment of FIGS. 5A-5C, FIGS. 6A and 6Billustrate additional detail of one embodiment of the proximal portionof the cannulated guide 40, including handle 41. The cannulation 44 maypass completely through the length of the guide, as shown, such that thecannulation extends through the handle 41 and out the proximal-most end91 of the guide and handle. The cannulation may include a shoulder orstop 43 which may interact with the stop 23 of the inserter 20 (or asimilar structure on the drill 60, discussed below) to limit distalmovement of the inserter through the cannulated guide. In oneembodiment, the laser mark 81 (or gap of material, or the like) of theinserter 20 may be positioned on the shaft 22 such that, upon contact ofthe stop 23 and stop 43, the laser mark 81 aligns with the proximal-mostend 91 of the handle 41. Furthermore, as discussed in greater detailbelow, the proximal-most end 91 of the handle 41 may include a colormarking thereon to designate, to the surgeon, that the cannulation 44has a specific, known, diameter. This may be particularly beneficial ifthe surgeon has a plurality of guides 40 and inserters 20 and/or drills60, for example as in a kit of such instruments, such that the surgeonmay use such color coding to use the proper guide and inserter/drillcombination (as mentioned below, the inserters and drills may also havesuch color coding, for example on a proximal portion, such as handle 21of the inserter 20 or on bushing 67 of the drill).

FIGS. 7A and 7B illustrate another embodiment of a cannulated guide 140including a proximal portion having a handle 141 and a distal portionincluding a distal tip 145, and a shaft 142 positioned between handle141 and distal tip 145. In this embodiment, contrary to guide 40, theshaft 142 may include a curve 149 along at least a portion of itslength, as illustrated in FIG. 7A. The curve may have an angle ofcurvature suitable for a particular procedure, approach angle to ananatomical location, a specific anatomy, or the like. For example, theguide 141 may have a curve 149 having an angle of curvature greater than0 degrees up to and including about 180 degrees. Preferably, the curvemay have an angle of curvature of, for example about 12 degrees or about25 degrees. Additional examples of curved guides are disclosed inco-pending applications, assigned to the same assignee as the presentapplication, including U.S. application Ser. No. 13,368,730, and U.S.Publication Nos. 2011/0015674, 2011/0015675 and 2011/0208194, theentireties of which are hereby incorporated by reference herein as iffully set forth herein. Of course, cannulated guides having multiplecurved portions, with similar or different angles of curvature, are alsowithin the scope of this invention.

It should be noted that any of the disclosed cannulated guides may alsobe in the form of a slotted guide (not shown), wherein the slotted guidedoes not include a guide having a complete, uninterrupted, cylindricalshape, but instead includes an incomplete cylindrical shape. Thus, sucha slotted guide would include a channel through the interior of theslotted shape rather than a cannulation.

Continuing with this embodiment, FIGS. 7A and 7B may include variousstructures adapted to designate to the surgeon in which direction thecurve 149 is positioned. Such structures may be particularly usefulwhen, for example, the guide is positioned within the patient duringarthroscopic surgery. First, the handle 141 may include an indent 195positioned on the handle relative to the curve 149. As in FIG. 7A, theindent 195 may be positioned on the handle 141 on substantially the sameside as the curve 149 is angled towards. In this example, the curve 149is angled in an upward direction, and the indent 195 is also positionedin an upward direction, on the upward portion of the handle 141. Ofcourse, the relative positioning can be altered as desired. Moreover,the indent 195 as illustrated is shaped such that the surgeon canposition a thumb therein, though other shapes may also be incorporatedsuitable for positioning a finger, a portion of the palm, or the liketherein. Further, the handle may include a plurality of indents, any ofwhich may be used to designate the curve. Second, as illustrated in FIG.7B, the proximal-most portion 191 of the handle 141 may include a lasermark or other marking 192 which may also be used by the surgeon toorientate the curve 149 when not being able to see the curve, e.g., whenthe distal portion of the guide is positioned within the patient.

In another embodiment (not illustrated), the guide of the presentinvention may include more than one curve along its length. For example,the guide may have a first curve, as discussed above, towards theproximal end of the guide. The guide may also have a second curve,proximal to the first curve. These curves may have trajectories, angles,and lengths different from one another or the same as one another, suchthat a multitude of various guides may be created. Such dual-curveguides may be particularly useful for surgical procedures with adifficult angle or direction of entry into the anatomy, such as a hiplabrum repair or the like.

A further embodiment of a cannulated guide is illustrated in FIGS.8A-8C, which illustrates a cannulated guide 240 including a shaft 242and a distal tip 245 having an engagement surface 247 which may be used,for example, in procedures for repairing a hip labrum tissue. Thesurface 247, rather than a “crown” shape, instead includes an angledface extending to a distal-most end 248 a of the angled face. Asillustrated for example in FIG. 8B, the angled face is designed to havean angle which is not perpendicular, relative to a longitudinal axis ofthe cannulated guide. The angled face also includes an at least one edgeengagement feature 248 b which may be positioned on the engagementsurface to provide a prescribed offset from an anatomical edge or otherfeature of the bone 105. As illustrated, the edge engagement feature 248b is positioned on the engagement surface a distance away from thedistal-most end 248 a. Such a configuration as illustrated may bebeneficial for use in repairing a hip labrum tissue, for example,because of the angle of approach to the anatomy the surgeon must use, aswell as the shape of the bone 105 to which the labrum tissue will beattached. This type of distal tip 245 may provide for sufficientengagement of the distal tip to the anatomy despite the angled approachto the anatomy. FIG. 8C illustrates such an engagement with the anatomyof the acetabulum 105 of the hip, for example.

The engagement feature 248 b may have a cross-sectional shape suitablefor engagement with the bone. For example, the cross-sectional shape maybe a “c” shape, a “u” shape, a “v” shape, or the like. For example, asillustrated in FIG. 8B, the engagement feature 248 b has a “c”cross-sectional shape. The distal tip 245 may also include a window 246through a portion of the sidewall of the guide. The guide, asillustrated in FIG. 8A may include at least one curve 249, oralternatively, two or more curves, along at least a portion of itslength. As with other embodiments, if two or more curves are presentalong its length, the various curves may have trajectories, angles, andlengths different from one another or the same as one another. The curveor curves, angle of the engagement surface 247, positioning and numberof at least one edge engagement feature 248 b, and the like may bedesigned and manufactured for optimal ease of use in navigating thesurrounding anatomy of the hip, for example, and for proper engagementto the specific portion of bone 105, such as the acetabulum 105. Whilethis embodiment is directed to an exemplary use in reattaching a hiplabrum to the acetabulum, this guide may be used in other joints andapplications where an angled engagement surface, and an at least onecurve, would be useful or preferred.

FIGS. 9A-C illustrate one embodiment of the loading device 50 of thepresent invention. The loading device includes a casing including anupper casing 51 a and a lower casing 51 b in a hinged relationship alonga side of the device 50, such as hinges 53. The loading device 50, as inFIG. 9B, includes a first side 52 a, a second side 52 b, a third side 52c, and a fourth side 52 d. In the illustration, the hinges 53 arepositioned along the second side 52 b of the device 50, though thehinges, or other like connection structure, may be positioned alongother sides, as desired. Alternatively, upper and lower casings 51 a, 51b, may be completely separate, such that they may be pulled completelyapart from one another. As illustrated, the upper and lower casings 51a, 51 b may, in a closed position, house at least a portion of thefilamentary fixation device 10 and at least a portion of inserter 20(FIGS. 9A and 9B illustrate two different sized inserters forillustrative purposes, preferably, only a single inserter would bepositioned within loading device 50). Both upper and lower casings maybe constructed of plastic or like material and may further betransparent to allow viewing through the casing and to the device 10 andinserter 20, when the casing is in the closed position (FIG. 9B).Preferably, the casing may be constructed of PMMA, specificallyPlexiglas®, PETG, or the like. As in FIG. 9C, the upper and lowercasings also define a first channel 54 extending from the first side 52a to the second side 52 b. The upper and lower casings may furtherdefine a second channel 55 extending from the first side 52 a to thethird side 52 c. Both the first and second channels may have a routewithin the casing, examples of such routes are circuitous or tortuousroutes as illustrated in detail in FIG. 9C.

Continuing this embodiment with reference to FIG. 9C, the first andsecond channels 54, 55 may overlap with one another along a portion oftheir route, such as at location 57. Location 57 may further be adaptedto maintain device 10 therein, such that the device 10 is positionedalong the route of both channels 54, 55. At least one pin 57 a, 57 b mayalso be positioned within at least one of the channels, preferablywithin location 57, where the pin or pins 57 a, 57 b may assist inmaintaining the device 10 within location 57 by, for example, puncturingthrough a portion of device 10 to secure the device in a desiredlocation. Within first and second channels 54, 55 may be positionedfirst and second threading filaments 56 a, 56 b, respectively,constructed of wire, suture, or the like. The threading filament 56 amay include a filament connector 56 a′ on a portion of the threadingfilament 56 a adjacent the first side 52 a, and threading filament 56 bmay include a filament connector 56 b′ on a portion of the threadingfilament 56 b also adjacent the first side 52 a. As will be explained indetail below, the threading filaments 56 a, 56 b may be used to threadthe filament 15, which may already be secured to tissue, a sutureanchor, or the like, through the filamentary fixation device 10.Filament connectors 56 a′, 56 b′ may be used to engage the filament ends17′, 18′.

Opposite ends 56 a″, 56 b″ of the threading filaments 56 a, 56 b mayextend from the opposite ends of the channels 54, 55 and out the secondand third sides 52 b, 52 c, respectively, and may be accessible to thesurgeon, such that the surgeon may, for example, tension these oppositeends to pull filament connectors 56 a′, 56 b′ (and filament ends 17′,18′) towards channels 54, 55, respectively. Preferably, and asillustrated in FIG. 9B, the loading device 50 may further includeloading actuators 59 a, 59 b positioned on the loading device,preferably adjacent the locations where opposite ends 56 a″, 56 b″ exitfrom channels 54, 55. The loading actuators 59 a, 59 b may be slideable,or otherwise actuable, relative to the casing 51 a, 51 b. In thisembodiment, the loading actuators may slide along sliding grooves 58 a,58 b on upper and lower casings 51 a, 51 b. The loading actuators mayalso include a filament lock 59 a′. 59 b′ through which, for example,the threading filaments 56 a, 56 b may be positioned. Thus, as thesurgeon actuates the loading actuators, by moving them rearwards alongthe casing, towards side 52 d (from the position shown in FIG. 9B to theposition shown in FIG. 9A), the threading filament may be tensioned suchthat the filament connectors 56 a′, 56 b′ (and filament ends 17′, 18′)move towards, and into, channels 54, 55, respectively. Additionally, theloading actuators may also hold the upper and lower casings in a foldedrelationship (FIG. 9B) such that, once they have been slid rearwards,and off of the sliding grooves 58 a, 58 b, the upper and lower casingsmay be moved to an open relationship (FIG. 9A).

Illustrated in FIGS. 10A and 10B is one embodiment of a drill 60 of thepresent invention, including a distal drill tip 61, a proximal portionincluding a chuck 62 for connection to a power drill (not shown) and ashaft spanning a length between the distal tip and the chuck. The drilltip 61 may be any drill tip suitable for penetrating bone and/or softtissue. The chuck 62 may be any suitable structure for engagement with apower drill. The shaft includes a proximal portion 63 and a distalportion 65, and as illustrated, the distal portion 65 may have a smallerdiameter than the proximal portion 63. Between the proximal and distalportions of the shaft may be a shoulder or stop 66, which may be, forexample, a shoulder for engagement with a guide, such as cannulatedguide 40. Stop 66 is similar to stop 23 of inserter 20 such that eithermay be engageable with the same cannulated guide 40 and stop 43. An atleast one laser mark 64, similar to laser mark 81 on the inserter 20,may also be positioned on the shaft, preferably, and as illustrated, onthe proximal portion 63 of the shaft. Alternatively, the shaft may havea gap of material, or the like. At least a portion of the shaft, such asfor example at least a portion of the distal portion 65 of the shaft,may be flexible such that it may pass through a curved cannulated guide(see FIG. 7A). The shaft may be constructed of any material which isstrong enough to withstand drilling forces when preparing a bore hole inbone, but flexible to pass through a curved cannulated guide. Forexample, stainless steel, Nitinol, or the like may be suitable, and morespecifically, a Nitinol K-wire, may be used for at least the distalportion 65 of the shaft. The Nitinol K-wire may, for example, maintainsufficient flexibility to pass through the curved cannulated guide up toa temperature of about 40 to about 60 degrees Celsius.

Drill 60 may further include a bushing 67, the bushing 67 includes asolid portion 68 and an at least one spring portion 69 a along itslength. The spring portion includes a resilient member, such that thespring portion can be compressed, expanded, or both. Bushing 67 may bepositioned towards the distal end of the drill, on the distal portion 65of the shaft. Upon activation of the drill, the bushing may eitherrotate with the drill (and therefore, be at least in part secured to thedrill), or the drill may rotate within the bushing. The bushing may beslideable along at least a portion of the length of the distal shaft 65and may further be compressible along the spring portion 69 a orportions 69 a, 69 b, 69 c, 69 d, 69 e as illustrated. The bushing maygenerally be flexible or elastic as well, to fit through a cannulatedguide having a curve (see FIG. 7A). Suitable materials for use in thebushing may include stainless steel, Nitinol, PEEK, Radel, ABS,Polycarbonate, Polyethylene, PTFE or the like. Such polymer materialsfor the bushing may reduce or eliminate metallic debris created whiledrilling, which can be an issue especially when drilling through acurved guide as in the present invention. The spring portion 69 a, orportions 69 a, 69 b, 69 c, 69 d, 69 e, includes a resilient member andmay be constructed of spring-like material which is then secured (e.g.,welded, adhered, or the like) to the solid portion 68 as well as spacerportions 68 a′, 68 b′, 68 c′, 68 d′, 68 e′. In one preferred example,illustrated in FIGS. 10A-10B, the solid portion and spacer portions maybe constructed of PEEK while the spring portions, illustrated as havinga spring structure, may be constructed of stainless steel. Suchmaterials themselves may also impart flexible, expandable, compressible,and the like characteristics which can be beneficial for the operationof the bushing, as explained in certain of the alternative embodimentsbelow.

Bushing 67 may, along at least a portion of its length, have an innerdiameter sufficient to impart a press-fit on the shaft of the drill. Forexample, a proximal portion of the bushing may have such a smallerdiameter to minimize proximal movement of the entire bushing. Instead,as the drill is pressed distally, and a distal portion of bushingcontacts one or both of the bone surface or the distal portion of thecannulated guide, the spring portion 69 a compresses such that thedistal portion of the bushing compresses towards the proximal portion ofthe bushing. In one example, at a drill depth of about 20 mm, which isthe preferred maximum depth of the bore hole, the springs supply anelastic force of about 0.5-10 lbs, more specifically about 1-4 lbs.Subsequently, once the bore hole is prepared, and the distal pressing(by the surgeon) is eased, the spring portion 69 a expands such that thedistal portion of the bushing moves closer to the distal tip 61 of drill60 as the drill is removed from the bone, such that the bushing returnsto its original position. While the spring portion does not in thisembodiment force the drill to withdraw from the bone, the spring portiondoes allow the bushing to return to its original position upon removalof the drill from the bone. It should be noted that such compression ofthe bushing may also occur, for example, as the drill and bushing movesthrough a curved cannulated guide 140, in that as the bushing and drillmove through the curve 149, the bushing may compress to allow the distaltip 61 room to navigate the curve. Once the distal tip 61 and at least aportion of the bushing 67 is through the curve, the spring portion 69 amay decompress such that the distal portion of the bushing moves towardsthe distal tip 61 and to its original position.

The bushing 67 may maintain the drill 60 in a central location withinthe cannulated guide, e.g., substantially co-axial to the longitudinalcenterline, or axis, of the guide 40. This may be particularly importantwhen using a curved guide (as in FIG. 7A) because the curve of theguide, and the elastic properties of the drill shaft, may cause thedrill to move off-center from the longitudinal axis of the guide uponexiting the guide such that the drill abuts one side of the guide. Thebushing may minimize this movement, such that the drill remainssubstantially in the center of the guide, and along the longitudinalaxis of the guide, even through the curve and after the curve, whichprovides for increased accuracy of placement of the bore hole by thedrill tip 61.

The bushing 67 may also assist the surgeon in providing a “shockabsorbing” or dampening system to the drill, particularly when the drilltip 61, for example, progresses through the cortical layer of bone andinto the softer cancellous layer. The spring characteristics of thebushing 67 provides for a smoother transition when passing into thecancellous by absorbing some of the forces applied on the drill tipthrough pressure applied by the surgeon. Furthermore, where multiplespring portions 69 a, 69 b, 69 c, 69 d, 69 e are present on the bushing,the various spring portions may have various spring constants such thatthe surgeon may obtain feedback through the varying spring tension andthe depth of the bore hole being formed. For example, as the surgeonforms the bore hole, and as the bore hole trends deeper into the bone,each spring portion, each having increased stiffness, may compresssequentially. Thus, it becomes more difficult to compress the bushingthe deeper the hole is drilled into the bone (and the further thebushing is compressed). Therefore, as the difficulty increases, thesurgeon knows the intended depth is being achieved. Of course, the stop66 may still be present to ensure that the surgeon does not drill thebore hole too deeply, and thus the increasing difficulty associated withthe compressing spring provide the surgeon a warning that the stop 66 isapproaching.

In an alternative configuration, the bushing may also serve to assist inretracting the drill tip 61 upon completion of the bore hole. Generallyspeaking, in this variation, when the surgeon completes the bore hole,and releases the downward pressure applied on the drill, the springcharacteristics of the bushing may assist in retracting the drill tipproximally back towards the cannulated guide. In applying such “spring”forces, the distal-most end of the bushing may engage one or both of thebone or tissue surface or the distal end of the guide, such that thespring portions compress between the force applied by the surgeon andthe abutment of the bone surface and/or a surface of the guide (forexample, an indented shoulder or the like (not shown)). In order for thespring to assist in retracting the drill from the bone, a much higherspring force would likely be needed, likely about 10 lbs.

Further, again with relation to the cannulated guide 40, the solidportion 68, situated at the distal portion of the bushing 67, mayprevent the spring portions from contacting the end of the cannulatedguide, or other structure, which could potentially catch on the distalend of the guide, which is particularly possible in the event the drilland bushing are inserted through the guide when the guide is notpositioned against a hard surface, such as bone. In order to minimize orprevent such an occurrence, the solid portion 68 is at least about 20mm, and preferably about 25 mm. This dimension, while not particularlylimited when using a straight guide 40, this dimension of the solidportion may be limited when used with a curved cannulated guide 140 asit may be too difficult to move a larger solid portion 68 through thecurve 149.

It should be noted that such bushings may also be used in conjunctionwith the inserter 20, which may provide for increased precision inimplantation and insertion of the device 10 into a bore hole,particularly if a curved cannulated guide 140 is used. Alternatively, itmay be desirable to use a bushing on the inserter if a larger,“universal,” guide is used. In such a configuration, a bushing may bedesirable for compatibility of the smaller implant and inserter (ordrill) with the larger guide.

Alternative embodiments of the bushing are illustrated in FIGS. 11A-C asbushing 167, 267, 367 positioned on the distal portion 65 of the shaftof drill 60. Bushing 167 is similar to the bushing 67, though bushing167 may include solid portion 168 a as well as an at least second solidportion 168 b positioned between spring portions 169 a, 169 b. In thisembodiment of FIG. 11A, where multiple springs are utilized in thebushing, it may be beneficial to separate them by solid portions 168 bto reduce metallic debris during drilling and to reduce the likelihoodof the spring ends tangling in each other. Solid portions 168 b may beconstructed of the various polymers discussed above, though othermaterials such as stainless steel may be used, particularly inapplications where the creation of metallic debris is less of a concern(e.g., when a guide having a mild curve, or no curve, is used).

As illustrated in FIG. 11B, bushing 267 may include only a solid portion268 such that it does not include a spring portion along its length.Such a configuration may be sufficient to maintain the drill in acentral location within the cannulated guide. Additionally, such abushing may not have the above-mentioned spring characteristics, suchthat the bushing may act as an additional “hard stop” against one of thebone surface or a surface of the cannulated guide 40. Alternatively,bushing 267 may have a sufficient inner diameter such that the bushingmay travel along the shaft a sufficient distance such that the bushingdoes not form a hard stop, but instead merely ensures that the drillremains in a central location within the guide. In both instances, thebushing may have to be manually retracted, by the surgeon, to itsoriginal starting position to create the desired “hole centering” insubsequent drill holes. Bushing 267 may be constructed of stainlesssteel, PEEK, or the like.

Bushing 367 is another alternative embodiment where substantially theentirety of the bushing is a spring portion 369, which operates asdescribed above with reference to bushing 67. Bushing 367 may beconstructed of, for example PEEK or Nitinol, or like material capable ofproviding the aforementioned spring characteristics. The bushing 367 maybe manufactured from a solid piece of material and include an at leastone cut, where the cut imparts the spring characteristics (resiliencysuch as compressibility, expandability, both, or the like). For example,the bushing 367 may be manufactured from a solid piece of material, suchas PEEK, and subsequently spiral cut or molded to form the illustratedshape. Thus, in this embodiment, the entirety of the bushing 367 itselfoperates as the spring.

Typically, when used through a straight cannulated guide 40, forexample, a drill having a small diameter may be used, such that thedrill may have a diameter sufficient to form a bore hole of about 1.4 mmup to about 1.9 mm. However, if a curved cannulated guide 140 is used, aslightly larger drill 60 should be used to create a bore hole of about2.3 mm. The larger dimension of the bore hole may provide easierinsertion of the filamentary fixation device 10 through the curved guideand into the bore hole.

The present invention may also include various systems and kits based onthe various instruments and devices discussed above. While it isenvisioned that these various devices and instruments may be utilized,packaged, sold, or designed in any number of systems and kits, a fewrepresentative embodiments will be discussed in detail below.

In one embodiment, the present invention includes a system for therepair of soft tissue, the system including at least one instrumentadapted to implant a filamentary fixation device into bone, and thefilamentary fixation device 10. The system may further include at leastone filament adapted to cooperate with the fixation device. The at leastone instrument may be any or all of the above-discussed instruments usedin implanting the fixation device 10.

In another embodiment, the present invention may include a systemincluding at least one instrument for implantation of a filamentaryfixation device, such as a cannulated guide 40 and an inserter 20. Thesystem may further include a drill 60. The cannulated guide 40 includes,at its proximal-most end 91 of the handle 41, a color marking which maydesignate to a surgeon that the cannulation is sized to fit an inserter,or drill, having a certain dimension. As discussed throughout, thepresent invention includes two exemplary sizes of about 2.3 mm and about1.4 mm. Thus, the color marking of these two various sizes would bedifferent such that, for example, the 2.3 mm cannulated guide 40includes a black color marking, while the 1.4 mm guide includes a tancolor marking. Of course, other color pairs easily discernible by thesurgeon may be used. The inserter 20 of the matching dimension may alsoinclude the same color marking at some location on its structure. Thedrill 50 of matching dimension may also include the same color, such as,for example, the bushing 67 may be of the designated color. Thus, inthis system, the surgeon can simply use matching colors to find thecorrect guide and inserter pair having the selected diameter. Of course,such color marking is particularly useful to a surgeon having aplurality of guides and inserters at his disposal.

In addition to the color marking, this system may further include anadditional characteristic to discern between two different sizes ofguides and inserters. Specifically, portions of the shaft of the twosizes of inserters may have differing dimensions. In a preferredembodiment, the proximal shaft 22 of the exemplary 1.4 mm inserter 20may be larger than the proximal shaft 22 of the exemplary 2.3 mminserter 20. Thus, it would not be possible to use the 1.4 mm inserter(and associated filamentary fixation device 10) with the 2.3 mmcannulated guide. Conversely, the 2.3 mm inserter could not be used withthe 1.4 mm cannulated guide because the distal portion 30, distal shaft24, and filamentary fixation device 10, of the 2.3 mm inserter would betoo large to fit through the 1.4 mm cannulated guide.

Additionally, the drill 50 would have similar dimensions to the inserter20, such that, for example, the proximal portion 63 of the shaft of a1.4 mm drill would not be capable of fitting into a 2.3 mm cannulatedguide. Conversely, the distal tip 61, bushing 67, and potentially eventhe distal portion 65 of the shaft of a 2.3 mm drill 50 would be toolarge to fit through a 1.4 mm cannulated guide.

Moreover, this system may have additional features to ensure thatcertain inserters and drills match with the correct cannulated guides.It should be noted that slotted guides may also be used in this system.For example, as discussed above, the guide may be offered in a varietyof lengths, e.g., 5.2 inches and 7.1 inches. For each of the above widthdimensions (1.4 mm and 2.3 mm), a single inserter or a single drill maybe suitable for use with a guide (having the same width dimension) ofeither length. For example, as illustrated in FIGS. 6A and 6B, theexemplary cannulated guide 40 may be a 5.2 inch guide. Within thehandle, proximal to stop 43, may be positioned a proximal bushing 43′having a diameter sufficient to accommodate the proximal shaft 22 of aninserter 20 (or drill 50). The proximal bushing 43′, having thisrelatively short length, is particularly dimensioned such that thedistal portion 30 of inserter 20 protrudes from the distal portion 45 ofthe guide 50, as illustrated in FIG. 6A. Of course, if the distalportion of the guide were extended as in, for example, the 7.1 inchguide, the distal portion 30 of the inserter may not protrude from theguide at all. Thus, in such an alternative configuration, the proximalbushing of the 7.1 inch guide (not shown) may be longer such that thestop is distal of the position illustrated in FIG. 6B. In somearrangements, the stop may be moved distally a sufficient amount suchthat the handle 21 is capable of abutting the handle 41 of the guide 50,such that a stop is effectively formed between the two handles (thedistal end of handle 21 and the proximal end of handle 41). It isenvisioned that the above precaution is still used in these variousguides such that, for example, the proximal shaft of a 1.4 mm insertercannot fit into the proximal end (and proximal bushing) of a 2.3 mmcannulated guide, regardless of whether the guide is of a length of 5.2inches or 7.1 inches.

As mentioned above, the cannulated guide 40 and drill 50 of this systemhave similar color markings and shaft sizes, dimensions andstops/shoulders which prevent the surgeon from using the wrong drillwith a particular guide. For example, as above, a single drill 50 may beused with either a long or a short guide (though the width dimensionmust match between the guide and drill, as discussed above). Similar tothe inserter 20, the drill 50, when used with the shorter guide,contacts stop 43 with stop or shoulder 66. However, when used with alonger guide, the chuck 62 may contact the proximal end of handle 41. Ofcourse, the shoulder may still contact the stop (now positioned distallywithin the handle) if the dimensions are so constructed.

In another embodiment, the present invention may include a kit includinga plurality of cannulated guides 40 and a plurality of inserters 20. Thekit may further include a plurality of drills 50, and further aplurality of bushings 67 for the drill. The bushings may be positionedon the drills, or alternatively, the bushings and drills may be separateand a surgeon can combine a desired drill with a desired bushing.Preferably, each drill has a bushing positioned thereon and the surgeonmay need only to select the desired drill (with bushing alreadyattached).

Further as to this embodiment, the plurality of guides may have variousinner diameters, of the cannulation 44, various overall lengths, variouscurves 149 ranging from and including 0 degrees up to and includingabout 180 degrees, or any combination of these dimensions or otherdesireable dimensions or features.

Such a kit may also include at least one of the plurality of guideshaving two curves along its length, such as one curve at a positiontowards the proximal end of the guide and a second curve, as illustratedthroughout, towards the distal end of the guide. Additionally, theplurality of guides may include a plurality of guides having two curves,each of which may have various combinations of first and second curveshaving different lengths, trajectories and angles, though of course someof such guides may include first and second angles which are themselvesthe same as compared to one another, but differ from other guides in thekit. The various angles of curvature available may be in set increments,such as in one preferred embodiment, the plurality of guides may includecurves of 0 degrees, 12 degrees and 25 degrees. As one example of otherfeatures which may be varied within the plurality of guides may concernthe distal tip 45, and specifically the shape of the surface 47, suchthat other arrangements rather than the “crown” shape, or the angledface of surface 247, may be available to the surgeon in this kit.

Continuing with this embodiment, the plurality of inserters 20 may havevarious width dimensions, various length dimensions, various distal-mostend shapes (forked, flat blade, etc.), or any combination. The pluralityof drills 50 may also include various width dimensions, various lengthdimensions, various types and shapes of bushings, and various drill tips61.

Additionally, this embodiment of the kit may include other devices andinstruments such as awls, trocars. The kit may further include at leastone filamentary fixation device 10 and at least one loading device 50.The fixation device 10 may be a plurality of fixation devices havingvarious lengths, widths, and the like. For example, as above, the kitmay include a device 10 suitable for use with the 1.4 mm instruments anda device 10 suitable for use with the 2.3 mm instruments. The kit mayalso include at least one filament 15 and at least one threadingfilament 56 a. Of course, the above-discussed color markings on thevarious instruments can be particularly helpful with this type of kit tosimplify the selection of the appropriate instruments and devices by thesurgeon for a particular surgical application, anatomy, or the like.

In another embodiment, the present invention may include a system,illustrated for example in FIGS. 9A-9C, including a loading device 50,an inserter 20 and a filamentary fixation device 10. The system may beassembled as in FIG. 9B and ready for immediate use (e.g., sterilizedand packaged in this configuration). The system may further include atleast one threading filament 56 a, and preferably two threadingfilaments 56 a, 56 b, also assembled with the loading device andfilamentary fixation device as illustrated in FIG. 9C, for example. Thesystem may also include a filament 15. The system may also include acannulated guide 40, 140 and optionally a drill 60.

In yet another embodiment, the present invention may be a kit includinga plurality of assemblies, each assembly having a loading device 50, afilamentary fixation device 10, and an inserter 20. Each of theplurality of assemblies may have various characteristics and dimensionsfrom which a surgeon may select the appropriate assembly for aparticular surgical application. Various differences between eachassembly of the kit may relate to the size or shape of the device 10(and corresponding inserter 20 size and shape), the path of the channels54, 55 through the loader and device 10, or other configuration ordimensions as discussed herein. Any of the plurality of assemblies maybe used with a filament 15, which also may be included in the kit. Thekit may further include pluralities of drills 60 and cannulated guides40, 140 (or slotted guides) which may be used with the various inserters20 and devices 10 within the plurality of assemblies.

In yet a further embodiment, the present invention may include a systemincluding a cannulated guide 40, 140 (or alternatively a slotted guide),an inserter 20 and a filamentary fixation device 10. The dimensions ofthe cannulated guide may be suitable for use with the inserter 20 andfilamentary fixation device 10, as discussed in depth above. The systemmay further include a drill 60, which may include a bushing 67, which isdimensioned for use with the cannulated guide 40, 140.

Any aspect of the above present invention may be disposable or otherwiselimited to a single use. For example, the loading device 50 may bedisposed after a single use. This is particularly for ease of usepurposes, as rethreading the threading filaments 56 a, 56 b can bedifficult. However, of course, the loading device 50 may be reloadableand reusable by, for example, rethreading the threading filaments 56 a,56 b with the upper case 51 a removed such that the channels 54, 55 areexposed. The drill 60 may be disposable or reusable, and similarly thebushing 67 may be reusable or reloadable. In one example, the drill maybe reusable, but the bushing may be disposable, such that a new bushingmust be engaged onto the drill before each use of the drill. Thecannulated guide 40 (or slotted guide) may be reusable, though they mayalso be disposable if so desired. The inserter 20 may also be eitherreusable or disposable.

In a further embodiment, the present invention may also include a methodof loading a filament 15 onto a filamentary fixation device 10, themethod including obtaining a first portion 17 having an end 17′ and asecond portion 18 having an end 18′ of the filament 15, positioning ends17′, 18′ into filament connectors 56 a′, 56 b′, respectively, ofthreading filaments 56 a, 56 b and securing same thereto. The threadingfilaments 56 a, 56 b are positioned within loading device 50, asillustrated for example in FIG. 9C. The opposite ends 56 a″, 56 b″ ofthe threading filaments (preferably using loading actuators 59 a, 59 b)may then be tensioned, and pulled proximally, by the surgeon, to drawthe filament ends 17′, 18′ into channels 54, 55 and through at least aportion of the device 10. Furthermore, the filament may, prior toengaging the filament with the threading filaments of the loadingdevice, be passed through a tissue, a suture anchor, or both.

In the particular embodiment illustrated in FIG. 9C, for example, eachend 17′, 18′ of the filament 15 may pass first, transversely throughdevice 10 such that the filament passed through a sidewall of the device10, through the hollow interior 11 and through the opposite sidewall.Upon exiting the sidewall, each end 17′, 18′ then follows the channels54, 55 in a generally circular path to one of a first end 12 and asecond end 13, and into the hollow interior 11 of the device 10. Theends 17′, 18′ of the filament, upon passing through the hollow interior,exit from the device 10 from the opposite of the first and second ends12, 13 from where they entered the device 10. The threading filamentsthen direct the filament ends 17′, 18′ through channels 54, 55 untilthey exit from the loading device on second and third sides 52 b, 52 c.The filament portions 17, 18 may then be grasped by the surgeon and thefilament ends 17′, 18′ may be disengaged from the filament connectors 56a′, 56 b′. At this point, the device is loaded with the filament, and,upon removal of the loading actuators 59 a, 59 b (if present), the upperand lower casings 51 a, 51 b may be separated and the surgeon may grasphandle 21 of the inserter 20. The first and second portions 17, 18 ofthe filament 15 may be tensioned and secured to the handle, such as byusing cleats 26 a, 26 b (FIG. 3C). The tensioning of the filamentportions may also cause the device to fold over saddle 33 of inserter20, as illustrated for example in FIG. 4, such that the device 10 nowsits within saddle 33 and grooves 32 a, 32 b. At this point, theassembly of the inserter 20, device 10 and filament 15 are ready forimplantation.

The present invention may also include a variety of surgical methods ofrepairing soft tissue, preparing a bone for attachment of soft tissue,or for use of the various instruments, devices, kits and systems. Whatfollows are certain exemplary embodiments using various instruments,devices, kits and systems, though of course, other variations to theseexemplary methods are also envisioned.

In one embodiment, the present invention includes a method of securingsoft tissue to bone. One aspect of such a method is disclosed in FIG.12, in which the soft tissue 200 is a shoulder labrum which is to besecured to bone 205, specifically, the glenoid. Of course, this specifictissue and bone is for illustrative purposes only, in that this methodmay be performed on other soft tissue and bone anatomies such as a hiplabrum, rotator cuff, or the like. In the example of the repair of a hiplabrum, the labrum, in that embodiment, is to be secured to theacetabulum.

In this method of FIG. 12, the soft tissue 200 and bone 205 are accessedvia an arthroscopic procedure (though open surgery may alternatively beperformed) and filament 15 is passed through the soft tissue 200 suchthat filament ends 17′, 18′ extend from the soft tissue. A bore hole 207may also be prepared in bone 205, into which the filamentary fixationdevice 10 and at least a portion of the filament 15 will be placed andsecured. The ends 17′, 18′ of the filament 15 may then be loaded, alongwith filament portions 17, 18, into the filamentary fixation device 10.In practice, the filament 15 may be loaded into device 10 using theloading device 50 (FIGS. 9A-C) as discussed above. Essentially, thefilament ends 17′, 18′ are positioned within filament connectors 56 a′,56 b′, respectively of threading filaments 56 a, 56 b and securedthereto. The opposite ends 56 a″, 56 b″ of the threading filaments(preferably using loading actuators 59 a, 59 b) may then be tensioned,and pulled proximally, by the surgeon, to draw the filament ends 17′,18′ into channels 54, 55 and through at least a portion of the device10. As illustrated in FIG. 9C, for example, each end 17′, 18′ of thefilament 15 may pass first, transversely through device 10 such that thefilament passed through a sidewall of the device 10, through the hollowinterior 11 and through the opposite sidewall. Upon exiting thesidewall, each end 17′, 18′ then follows the channels 54, 55 in agenerally circular path to one of a first end 12 and a second 13, andinto the hollow interior 11 of the device 10. The ends 17′, 18′ of thefilament, upon passing through the hollow interior, exit from the device10 from the opposite of the first and second ends 12, 13 from where theyentered the device 10. The threading filaments then direct the filamentends 17′, 18′ through channels 54, 55 until they exit from the loadingdevice on second and third sides 52 b, 52 c. The filament portions 17,18 may then be grasped by the surgeon and the filament ends 17′, 18′ maybe disengaged from the filament connectors 56 a′, 56 b′. At this point,the device is loaded with the filament, and, upon removal of the loadingactuators 59 a, 59 b (if present), the upper and lower casings 51 a, 51b may be separated and the surgeon may grasp handle 21 of the inserter20. The first and second portions 17, 18 of the filament 15 may betensioned and secured to the handle, such as by using cleats 26 a, 26 b(FIG. 3C). As illustrated for example in FIG. 4, once the filament 15 issecured to the handle, the device 10 now sits within saddle 33 andgrooves 32 a, 32 b. At this point, the assembly of the inserter 20,device 10 and filament 15 are ready for implantation.

Using the inserter, the device 10 is then implanted, along with at leasta portion of filament 15, into the bore hole 207. Once the implant ispositioned within the bore hole, the filament portions 17, 18 may beremoved from the handle 21 and the inserter may be removed. Any slack ofthe filament, between the tissue 200 and the device 10, may be reducedby further tensioning of filament ends 17′, 18′. Once the slack issubstantially minimized or removed, the filament 15 also tensions thetissue 200 such that the tissue 200 is moved to a position adjacent toor substantially over the bore hole 207. The portions 17, 18 of thefilament are then tensioned further, which ultimately results in thedevice 10 becoming secured within the bore hole, which thereby alsosecures the filament 15 within the bore hole. Additionally, as thefilament 15 is tensioned, the tissue 200 is drawn further to a positionsubstantially adjacent to or on top of the bore hole. The end portionsof the filament may be severed, and the access pathway to the surgicalsite may be closed.

It should be noted that the drilling of the bore hole 207 step may beperformed at any time during this method. For example, in onealternative, the bore hole may be prepared first, prior to passing thefilament through the tissue 200. Thus, a drill 60 may be passed througha cannulated guide 40, 140 (or slotted guide), and the bore holeprepared. The drill may then be removed from the guide and the stepsutilizing the filament 15 and device 10 may then be performed, eitherthrough guide 40, 140 or through a surgical cannula or secondarycannulated guide.

Such a method of repair may result in a strong reattachment of thetissue to the bone. The pullout strength of device 10 is at leastcomparable to conventional anchors, as well as currently availablefilamentary anchors, such that pullout loads of at least 30 lbs may becapable using device 10.

Illustrated in FIG. 13 is another embodiment of a method of the presentinvention, exemplified as a repair of a rotator cuff. Essentially, themethod incorporates a “suture bridge” configuration between a medialsuture anchor 301, as known in the art, and a lateral anchor in whichthe filamentary fixation device 10 is used within bore hole 307. In thismethod, the surgical site is accessed via arthroscopy (though opensurgery may alternatively be used), and the medial anchor 301 isimplanted under the tissue 300, as is known in the art. The anchor 301may be implanted through tissue 300 and into bone 305, or alternatively,the tissue 300 may be moved medially and the anchor 301 positioned inthe bone 305 without passing through tissue 300. A filament 15 isengaged with the anchor 301 through either a knot or by passing throughan eyelet or other structure on anchor 301, such that two end portions17, 18 of the filament extend from the anchor, terminating in ends 17′,18′. The two end portions are passed through the tissue 300, above theanchor 301 and as illustrated. The two portions 17, 18, extendingthrough the tissue, may optionally form a know 308, above the tissue, tocompress a portion of the tissue between the knot and the anchor 301.Alternatively or in addition, the bone anchor 301 may engage thefilament 15 such that the filament is fixed to the anchor and may notslide therethrough. The two portions 17, 18 may then be directedlaterally over tissue 300 and towards a bore hole 307 which is preparedas discussed above using drill 60. Bore hole 307 may be positionedlaterally outside of a native footprint of tissue 300, or alternatively,may be positioned adjacent to or at the edge of the native footprint.Preferably, the bore hole 307 is positioned lateral to the nativefootprint such that the tissue may be properly tensioned to create aneffective repair.

The filament 15 may then be loaded onto the filamentary fixation device10, as illustrated in FIG. 13, using a similar method as discussedabove. Once the filament is loaded, the device 10 and filament 15 areready for implantation, the steps for which are similar to those abovewith respect to FIG. 12. Additionally, particularly as to thisembodiment, the filament 15 creates a suture bridge over tissue 300 suchthat the tissue abuts the underlying bone 305 along as much of itssurface area of the native footprint as possible.

In one alternative embodiment, the method illustrated in FIG. 13 may berepeated such that two lateral bore holes are formed, two filaments,each having first and second end portions, extend from the medialanchor, and two filamentary fixation devices are used to secure the twofilaments within the two bore holes. Such a repair provides for an evenlarger amount of the surface area of tissue 300 to abut the underlyingbone 305. In yet another alternative, the two filaments may extend fromtwo separate medial anchors, such that two separate medial-lateralrepairs are performed in parallel. Other such configurations are alsoenvisioned, having varying amounts of medial and lateral anchors andfilaments.

In another embodiment, illustrated in FIG. 14, the present inventionincludes a method, similar to that disclosed in FIG. 13, except that inthis embodiment a single filament portion 17, having filament end 17′,may be used. The other filament portion 18 may be cut or otherwiseremoved and not used. As with the embodiment of FIG. 13, in thisembodiment, a bone anchor 301 is positioned medially in bone 305,underneath the tissue 300. At least one of the filament portions 17, 18,secured to the anchor 301, is passed through the tissue 30 andpositioned over the tissue in a lateral direction. Again, in thisexample, the tissue 300 is a rotator cuff, though this method may beperformed on other soft tissues. If both filament end portions 17, 18are passed through the tissue, a knot 308 may be formed to providefurther securement of the tissue to the bone. A lateral bone hole 307 isalso prepared. The end portion 17 of the filament 15 is loaded intofilamentary fixation device 10, as discussed above (e.g., using athreading filament 56 a (not shown)). The device 10, along with endportion 17 of the filament 15 are then implanted into bone hole 307. Theend 17′ is then tensioned to secure the filament 15 and device 10 in thebone hole and to tension and draw the rotator cuff laterally towards thelater bone hole 307.

FIG. 15 illustrates yet another embodiment of a method of the presentinvention. In this embodiment, rather than removing or not utilizing theother end portion 18, as in FIG. 14, filament end portion 18 is passed,along with end portion 17, through the tissue 300 (again, using rotatorcuff as an example). The end portions 17, 18 may then form knot 308.Both end portions 17, 18 may then be positioned laterally over thetissue. First and second lateral bone holes 307, 307′ may be preparedlaterally to the tissue. Typically, they are positioned lateral to thenative footprint of the, in this example, rotator cuff to provide forlateral tension on the tissue even once the tissue is reattached to itsnative footprint. As described above, and similar to FIG. 14, the firstand second ends 17′, 18′ are loaded onto first and second filamentaryfixation devices 10, 10′, respectively. This step is illustrated in FIG.15. The devices 10, 10′ along with end portions 17, 18, respectively, ofthe filament 15 are then implanted into respective bone holes 307, 307′.The ends 17′, 18′ are then tensioned to secure the filament 15 anddevices 10, 10′ in the bone holes and to tension and draw the rotatorcuff laterally towards the later bone hole 307.

In another alternative to this embodiment of FIG. 15, the method mayinclude two medial anchors, each having a single filament end portionsecured thereto. Each of the filament end portions may then bemaneuvered to secure to first and second devices 10, 10′, as discussedabove, to form a suture bridge repair utilizing four anchors and twolengths of filament. Of course, the filaments may be positionedlaterally to the two bone holes such that they form two parallel“bridges,” or alternatively, form an “X”-shaped bridge by crossing thefilaments prior to implantation of the devices 10, 10′ into bone holes307, 307′.

In another embodiment, the present invention may include a method ofrepairing tissue as is illustrated in FIGS. 16A and 16B. In thisembodiment, a filament 215 is used, filament 215 includes a filamentportion 217 and a filament end 217′ on one side, and a closed loop 216on the other. Such a filament is used in a tissue repair procedure usinga suture anchor in co-pending U.S. application Ser. No. 13/441,290,filed Apr. 6, 2012, owned by the same assignee as the presentapplication, the entirety of which is incorporated by reference hereinas if fully set forth herein. In this embodiment, the filament 215 ispassed around or through tissue 200, which in this embodiment isexemplified as shoulder labrum tissue. The end portion 217 may then bepassed through closed loop 216 and the end portion 217 may be tensionedto form a “luggage tag” configuration, as in FIG. 16B. the device 10 maythen be loaded onto the end 217′ and end portion 217 of filament 215, ashas been discussed in depth above. The device 10, along with end portion217 of filament 215, may then be implanted into bone hole 207. The end217′ may then be tensioned to secure the device and filament within thebone hole. Such tensioning may also tension the tissue 200 and draw thetissue towards and adjacent to, or over, the bone hole 207. Othervariations of this method are also envisioned, for example, utilizing afilament 215 which includes more than one end portion 217 extending fromthe closed loop 216, such that they may be used in a single device 10,or multiple devices.

In another embodiment, the present invention includes a system for therepair of soft tissue including at least one filament, at least onefilamentary fixation device, at least one instrument for insertion ofthe filament and fixation device, and a surgical procedure. The surgicalprocedure may include instructions or protocol for using the filament,fixation device, and instrument to repair soft tissue. The protocol mayinclude aspects of any of the above-discussed embodiments, though othervariations are also envisioned within the scope of the presentinvention.

In an associated embodiment, the present invention includes a method ofproviding instructions or information to practice any of the variousmethods of performing soft tissue repair described herein. For example,the method may include supplying a surgical protocol, or like document,to provide step-by-step instructions for performing any of the methodembodiments of the present invention.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

1.-17. (canceled)
 18. A method of repairing soft tissue, comprising thesteps of: forming a bore hole in bone; engaging a filament to the softtissue, the filament having at least one filament end extending from thetissue; engaging the at least one filament end of the filament with atleast one threading connector of a threading filament, the threadingfilament having a length between the at least one threading connectorand at least one opposite end, at least a portion of the length passingthrough a filamentary fixation device along a path; tensioning thethreading filament, from the opposite end, to move the filament alongthe path through the filamentary fixation device, such that the filamentengages the soft tissue to the filamentary fixation device; and securingthe filamentary fixation device, filament and soft tissue to the bone byimplanting the filamentary fixation device and at least a portion of thefilament, passing through the filamentary fixation device, into the borehole.
 19. The method of claim 18, wherein the securing step furthercomprises tensioning the filament to tension the soft tissue towards thebore hole, secure the filamentary fixation device and filament in thebore hole, or both.
 20. The method of claim 18, wherein a portion of thepath includes a generally circular path relative to the filamentaryfixation device.
 21. The method of claim 18, wherein the filamentincludes a second filament end, further comprising the step of engagingthe second free end of the filament with a second threading connector ofa second threading filament, the second threading filament having alength between the second threading connector and at least one oppositeend, at least a portion of the length passing through the filamentaryfixation device along a second path.
 22. The method of claim 21, whereinthe filamentary fixation device includes a first end and a second endand defining a length therebetween and a hollow interior along thelength, wherein the first path extends at least from the first end tothe second end and through the hollow interior and the second pathextends from the second end to the first end and through the hollowinterior.
 23. The method of claim 22, wherein upon tensioning the firstand second threading filaments, the filament includes a loop portionextending between the first and second ends of the filamentary fixationdevice and the soft tissue.
 24. The method of claim 18, wherein aportion of the path includes passing through a sidewall of thefilamentary fixation device.
 25. The method of claim 18, wherein thestep of engaging the filament to soft tissue further comprisespositioning a suture anchor adjacent to the tissue, to which a portionof the filament is secured, and passing the filament end through thetissue and to the threading connector of the threading filament.
 26. Themethod of claim 18, wherein the filament includes a second filament endforming a closed loop, wherein the step of engaging the filament to thesoft tissue further comprises passing one of the filament ends throughor around the tissue, passing the first filament end through the closedloop of the second filament end, and tensioning the first filament endto draw the closed loop to the soft tissue.
 27. The method of claim 18,wherein the step of engaging the filament to the soft tissue occursprior to the step of engaging the at least one free end of the filamentwith the at least one threading connector of the threading filament. 28.The method of claim 18, wherein during the step of engaging the at leastone filament end of the filament with the at least one threadingconnector of the threading filament, the filamentary fixation device andthreading filament are positioned between a plurality of pins.
 29. Amethod of loading a filament onto a filamentary fixation device,comprising the steps of: obtaining a filament having a first filamentend and a second filament end; engaging the first filament end of thefilament with a first threading connector of a first threading filament,the threading filament having a length between the at least onethreading connector and an opposite end, at least a portion of thelength passing through the filamentary fixation device along a firstpath, the filamentary fixation device including a first end and a secondend and defining a length therebetween and a hollow interior along thelength, wherein the first path extends at least from the first end tothe second end and through the hollow interior; engaging the secondfilament end of the filament with a second threading connector of asecond threading filament, the threading filament having a lengthbetween the second threading connector and an opposite end, at least aportion of the length passing through the filamentary fixation devicealong a second path, the second path extending from the second end tothe first end and through the hollow interior; and tensioning the firstand second threading filaments, from the opposite ends, to move thefilament along the first and second paths through the filamentaryfixation device.
 30. The method of claim 29, wherein the first andsecond threading filaments form a continuous threading filament,extending from the first threading connector to a second threadingconnector.
 31. The method of claim 29, wherein upon tensioning the firstand second threading filaments, the filament includes a loop portionextending between the first and second ends of the filamentary fixationdevice.
 32. The method of claim 29, wherein a portion of the first path,second path, or both first and second paths, includes passing through asidewall of the filamentary fixation device.
 33. The method of claim 29,wherein during the step of engaging the first and second filament endsof the filament with the first and second threading connectors of thethreading filaments, the filamentary fixation device and threadingfilaments are positioned between a plurality of pins.